Track&Trace: 'Fibrosis in the Lost Hepatitis C Population - Track, Trace and Treat'
Study Details
Study Description
Brief Summary
Objective:
To coordinate active tracing of chronic hepatitis C patients lost to follow-up to inform them about there disease severity and treatment options.
Study design: This is a prospective cohort study, which will start as a pilot study in the Radboudumc Population: lost to follow-up chronic hepatitis C patients in the region Nijmegen. This so-called lost population consists of all patients, that in the past have been identified at the Radboudumc but who are currently lost to or have been withdrawn from follow-up. The time-span of interest will be 2000-2015. We estimate that this project will retrace 100 lost patients through this search.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| lost to follow-up patients This so-called lost population consists of all patients, that in the past have been diagnosed with hepatitis C at the Radboudumc but who are currently lost to or have been withdrawn from follow-up. The time-span of interest will be 2000-2015. |
Outcome Measures
Primary Outcome Measures
- Liver Fibrosis Stage [Baseline]
Fibrosis stage according to elastography (liver stiffness in kPa) and/or liverbiopsy (staging according to Metavir). Stage F0/1 equals minimal fibrosis, stage F2 equals significant fibrosis and stage F3/F4 equals advanced fibrosis (including cirrhosis). For elastography, F0/1 is defined as liver stiffness <7.1 kPa, F2 as liver stiffness between 7.1 and 9.4 kPa and F3/F4 as liver stiffness >9.4 kPa. For liver biopsy, F0/1 is defined as the presence of no fibrosis or minimal fibrosis without the presence of septa, F2 as the presence of portal fibrosis with a few septa and F3/F4 as the presence of septal fibrosis or cirrhosis. The higher the fibrosis stage, the worse the outcome.
Secondary Outcome Measures
- Reasons for Loss to Follow-up [Baseline]
through chart review or questioning screening event
- Genotype Distribution [Baseline]
Genotype distribution among RNA-positive patients
- Fibrosis Progression [Baseline]
Fibrosis stage comparison in patients with a previously recorded fibrosis measurement, either with Fibroscan or liver biopsy. This previous measurement will be compared to the result of the Fibroscan performed during re-evaluation.
- Treatment Outcome [At least 12 weeks after end of treatment]
Sustained virological response in treated patients, defined as non-detectable HCV RNA at least 12 weeks after end of treatment
Eligibility Criteria
Criteria
Inclusion Criteria:
- ever diagnosed with hepatitis C, lost to follow-up
Exclusion Criteria:
- none
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Radboudumc | Nijmegen | Gelderland | Netherlands | 6500 HB |
Sponsors and Collaborators
- Radboud University Medical Center
- Merck Sharp & Dohme LLC
Investigators
- Principal Investigator: Joost Drenth, Md,PhD,Prof, Radboud University Medical Center
Study Documents (Full-Text)
More Information
Publications
None provided.- 2017-3198
Study Results
Participant Flow
| Recruitment Details | After identification of lost to follow-up hepatitis C patients, patients who were alive and residing in the Netherlands were invited for re-evaluation at the outpatient clinic. |
|---|---|
| Pre-assignment Detail | After invitation, patients could not be enrolled (defined as the signing of informed consent) for multiple reasons. These reasons are described below. |
| Arm/Group Title | Invited Lost to Follow-up Patients |
|---|---|
| Arm/Group Description | Alive patients who were anti-HCV and/or HCV RNA positive in the period 2000-2015 who have not been treated and were residing in the Netherlands, were invited for re-evaluation at the outpatient clinic. |
| Period Title: Overall Study | |
| STARTED | 106 |
| COMPLETED | 10 |
| NOT COMPLETED | 96 |
Baseline Characteristics
| Arm/Group Title | Re-evaluated Lost to Follow-up Patients |
|---|---|
| Arm/Group Description | Invited lost to follow-up patients who were seen at the outpatient clinic. |
| Overall Participants | 10 |
| Age (years) [Median (Inter-Quartile Range) ] | |
| Median (Inter-Quartile Range) [years] |
62
|
| Sex: Female, Male (Count of Participants) | |
| Female |
0
0%
|
| Male |
10
100%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
0
0%
|
| White |
10
100%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
0
0%
|
| Region of Enrollment (participants) [Number] | |
| Netherlands |
10
100%
|
| Country of birth (Count of Participants) | |
| Netherlands |
8
80%
|
| England |
1
10%
|
| France |
1
10%
|
| HCV transmission route (Count of Participants) | |
| Intravenous drug use |
7
70%
|
| Blood transfusion |
3
30%
|
| Years since last hospital contact (years) [Median (Full Range) ] | |
| Median (Full Range) [years] |
13.5
|
| Treatment experienced (Count of Participants) | |
| Count of Participants [Participants] |
5
50%
|
| RNA-positive (Count of Participants) | |
| Count of Participants [Participants] |
5
50%
|
Outcome Measures
| Title | Liver Fibrosis Stage |
|---|---|
| Description | Fibrosis stage according to elastography (liver stiffness in kPa) and/or liverbiopsy (staging according to Metavir). Stage F0/1 equals minimal fibrosis, stage F2 equals significant fibrosis and stage F3/F4 equals advanced fibrosis (including cirrhosis). For elastography, F0/1 is defined as liver stiffness <7.1 kPa, F2 as liver stiffness between 7.1 and 9.4 kPa and F3/F4 as liver stiffness >9.4 kPa. For liver biopsy, F0/1 is defined as the presence of no fibrosis or minimal fibrosis without the presence of septa, F2 as the presence of portal fibrosis with a few septa and F3/F4 as the presence of septal fibrosis or cirrhosis. The higher the fibrosis stage, the worse the outcome. |
| Time Frame | Baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| Liver fibrosis was only assessed in patients who were HCV RNA-positive at baseline, i.e. in 5 out of a total of 10 re-evaluated patients. |
| Arm/Group Title | RNA-positive Re-evaluated Lost to Follow-up Patients |
|---|---|
| Arm/Group Description | LTFU patients who were still RNA-positive at the re-evaluation visit. |
| Measure Participants | 5 |
| F0/1 (<7.1 kPa) |
3
30%
|
| F2 (7.1 - 9.4 kPa) |
1
10%
|
| F3/F4 (>9.4 kPa) |
1
10%
|
| Title | Reasons for Loss to Follow-up |
|---|---|
| Description | through chart review or questioning screening event |
| Time Frame | Baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Re-evaluated Lost to Follow-up Patients |
|---|---|
| Arm/Group Description | Invited lost to follow-up patients who were seen at the outpatient clinic. |
| Measure Participants | 10 |
| Patient: therapy refusal/contra-indication/no-show |
2
20%
|
| Therapy-related: no indication or options |
2
20%
|
| Care-related: no adequate follow-up planned |
5
50%
|
| Unknown |
1
10%
|
| Title | Genotype Distribution |
|---|---|
| Description | Genotype distribution among RNA-positive patients |
| Time Frame | Baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| HCV genotype was only determined in patients who were HCV RNA-positive at baseline, i.e. 5 out of a total of 10 re-evaluated patients. |
| Arm/Group Title | RNA-positive Re-evaluated Lost to Follow-up Patients |
|---|---|
| Arm/Group Description | LTFU patients who were still RNA-positive at the re-evaluation visit. |
| Measure Participants | 5 |
| 1a |
2
20%
|
| 1b |
2
20%
|
| 3a |
1
10%
|
| Title | Fibrosis Progression |
|---|---|
| Description | Fibrosis stage comparison in patients with a previously recorded fibrosis measurement, either with Fibroscan or liver biopsy. This previous measurement will be compared to the result of the Fibroscan performed during re-evaluation. |
| Time Frame | Baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| Fibrosis progression could only be measured if patients had a previous fibrosis measurement, either by liver biopsy or liver stiffness measurement. This was the case in 3 out of 5 HCV RNA-positive patients, or 3 out of 10 re-evaluated patients. |
| Arm/Group Title | RNA-positive Re-evaluated Lost to Follow-up Patients |
|---|---|
| Arm/Group Description | RNA-positive patients with a previous fibrosis measurement. |
| Measure Participants | 3 |
| No progression (F0/1 stayed F0/1) |
2
20%
|
| Progression (F0/1 became F4) |
1
10%
|
| Title | Treatment Outcome |
|---|---|
| Description | Sustained virological response in treated patients, defined as non-detectable HCV RNA at least 12 weeks after end of treatment |
| Time Frame | At least 12 weeks after end of treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | RNA-positive Re-evaluated Lost to Follow-up Patients |
|---|---|
| Arm/Group Description | LTFU patients who were still RNA-positive at the re-evaluation visit. |
| Measure Participants | 5 |
| Elbasvir/grazoprevir 12 weeks |
2
20%
|
| Glecaprevir/pibrentasvir 8 weeks |
2
20%
|
| Sofosbuvir/velpatasvir 12 weeks |
1
10%
|
Adverse Events
| Time Frame | Full duration of treatment: 8 or 12 weeks. | |
|---|---|---|
| Adverse Event Reporting Description | Adverse events could only be reported in treated patients. Only 5 out of 10 re-evaluated patients were HCV RNA-positive and therefore only 5 had to be treated. Adverse events for these 5 patients are presented. | |
| Arm/Group Title | Treated Patients | |
| Arm/Group Description | RNA-positive patients who received treatment with interferon-free direct antiviral regimens. | |
All Cause Mortality |
||
| Treated Patients | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/5 (0%) | |
Serious Adverse Events |
||
| Treated Patients | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/5 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Treated Patients | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/5 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Prof. dr. J.P.H. Drenth |
|---|---|
| Organization | Radboudumc |
| Phone | 0031243613999 |
| joost.drenth@radboudumc.nl |
- 2017-3198